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The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.

Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 weeks ]

The miR-122 seed sites in HCV RNA from subjects at baseline and following viral breakthrough or relapse will be subjected to genotypic sequence analysis.

Plasma pharmacokinetics [ Time Frame: 28 weeks ]

Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28.

Urine pharmacokinetics [ Time Frame: Up to 24 hours post-dose on Day 29 and Day 84 ]

Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.

Drug: Miravirsen sodium

Subcutaneous injection

Other Name: SPC3649

Eligibility

Information from the National Library of Medicine

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